NA 04.045.046SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982294456), received between Oct 18, 2022 and Feb 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A NAIL TREATING THE LOWER LEG. AFTER THE SURGERY, WOUND INFECTION OCCURRED. ON (B)(6) 2024, ONLY THE SCREWS THAT HAVE INTERFERED WITH THE WOUND WERE REMOVED IN A REOPERATION. PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 46MM/ XL25/ STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18777071 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A BROKEN TNA NEEDED REMOVING AND RE-NAILING. THE NAIL HAD BROKEN AT THE DISTAL END. THE NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2023, AND WAS REMOVED ON (B)(6) 2023 AND RE-NAILED WITH A 10X360MM TNA. ALL PREVIOUS NAIL ITEMS WERE REMOVED. THE REVISION PROCEDURE WAS PERFORMED BECAUSE OF THE BROKEN IMPLANT, THE FRACTURE HAD NOT HEALED. THE PATIENT HAD SIGNIFICANT DISTAL BONE LOSS AND A MASQUELET PROCEDURE WAS COMPLETED. THE PATIENT HAD BORNE WEIGHT AFTER BONE GRAFT HAD BEEN INSERTED, AND THIS IS WHEN THE NAIL BROKE. REAMINGS SENT OFF DURING THE CASE CAME BACK POSITIVE FOR INFECTION. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS PROGRESSING WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 46MM/ XL25/ STERILE. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 17975202 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A BROKEN TNA NEEDED REMOVING AND RE-NAILING. THE NAIL HAD BROKEN AT THE DISTAL END. THE NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2023, AND WAS REMOVED ON (B)(6) 2023 AND RE-NAILED WITH A 10X360MM TNA. ALL PREVIOUS NAIL ITEMS WERE REMOVED. THE REVISION PROCEDURE WAS PERFORMED BECAUSE OF THE BROKEN IMPLANT, THE FRACTURE HAD NOT HEALED. THE PATIENT HAD SIGNIFICANT DISTAL BONE LOSS AND A MASQUELET PROCEDURE WAS COMPLETED. THE PATIENT HAD BORNE WEIGHT AFTER BONE GRAFT HAD BEEN INSERTED, AND THIS IS WHEN THE NAIL BROKE. REAMINGS SENT OFF DURING THE CASE CAME BACK POSITIVE FOR INFECTION. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS PROGRESSING WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 46MM/ XL25/ STERILE. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 17975197 ↗
• InjuryOct 18, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR CONVERSION TO TOTAL HIP DUE TO CUT OUT. THERE WAS NO SURGICAL DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 46MM/ XL25/ STERILE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15620833 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, K201346. One submission often covers many models, so check the product and lot details in each record.

• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A
• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A